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Tristan Manalac

Tristan Manalac

Senior Staff Writer

Tristan is BioSpace‘s senior staff writer. Based in Metro Manila, Tristan has more than eight years of experience writing about medicine, biotech and science. Being formally trained in molecular biology, he once dreamed of collecting degrees and starting his own lab. But these days, he finds his greatest joy in a bottle of beer and a beautiful sentence. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.

Facade of Novo Nordisk's office in Fremont, California
Regulatory
Novo Makes Case to FDA That Semaglutide Is Too Complex for Compounders to Produce
Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding list, which includes drugs that are too complicated to produce and could pose substantial safety risks to patients if manufactured incorrectly.
October 23, 2024
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2 min read
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Tristan Manalac
Sangamo's headquarters in Silicon Valley
Regulatory
Sangamo’s Fabry Gene Therapy Could Hit Market 3 Years Earlier With FDA Accelerated Approval Pathway
The regulator agreed to allow Sangamo Therapeutics to use data to seek accelerated approval for its Fabry gene therapy candidate, eliminating the need for an additional registrational study and potentially shortening the time-to-market by three years.
October 23, 2024
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2 min read
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Tristan Manalac
FDA signage at its headquarters in Maryland
Complete response letters
FDA Rejects Camurus’ Rare Hormonal Disorder Treatment Due to Manufacturing Problems
The regulator cited deficiencies at a third-party manufacturing facility. Camurus is seeking approval for its extended-release subcutaneous formulation of octreotide, which would allow more convenient once-monthly dosing for patients with acromegaly.
October 22, 2024
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2 min read
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Tristan Manalac
Pictured: Eli Lilly Campus in San Diego
Legal
Lilly Ups Legal Offensive Against Tirzepatide Copycats as FDA Mulls Shortage Status
Monday’s lawsuits from Eli Lilly are the first to be filed by the pharma since the regulator officially removed tirzepatide from its drug shortage database earlier this month.
October 22, 2024
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2 min read
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Tristan Manalac
An empty conference room overlooking a city
Business
Activist Investor Starboard Takes Aim at J&J Spinoff Kenvue on Heels of $1B Stake in Pfizer
Starboard Value contends that Kenvue, with strong consumer health brands like Tylenol and Listerine, is underperforming its rivals, according to The Wall Street Journal.
October 22, 2024
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2 min read
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Tristan Manalac
A team of research scientists in protective equipment working in a lab
Manufacturing
Radiopharma-Focused CDMO Nucleus Unveils Two New Plants, Looks to Create 100 Jobs
Nucleus RadioPharma’s two sites are meant to help address the industry’s lack of manufacturing and development capabilities, as well as geographic limitations associated with the short half-life of many radioactive components.
October 22, 2024
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2 min read
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Tristan Manalac
Entrance to Vertex's office in Boston, Massachusetts
Pain
Vertex Unveils Full Phase III Data for Non-Opioid Pain Candidate, Touts Safety Profile
BMO Capital Markets analyst Evan Seigerman in a note to investors said the late-stage data for Vertex’s experimental non-opioid pain medication “reaffirms our confidence in the strength of suzetrigine’s profile.” However, William Blair analysts view these data as “an incremental positive” as the company faces challenges in targeting the acute pain market.
October 21, 2024
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3 min read
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Tristan Manalac
Pictured: Novartis' logo outside its building in S
Drug pricing
NJ Court Tosses Novartis’ Lawsuit Against Drug Negotiation Program in Latest Setback for Big Pharma
With Friday’s ruling by New Jersey District Judge Zahid Quraishi, Novartis joins a growing list of pharmaceutical companies that have failed in their legal challenges to the Inflation Reduction Act.
October 21, 2024
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2 min read
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Tristan Manalac
Pictured: Astellas' Americas headquarters in Illin
Approvals
Astellas’ First-in-Class, Claudin-Targeted Therapy Wins FDA Nod for Certain Gastric Cancers
The regulator’s approval on Friday of Vyloy for gastric or gastroesophageal junction cancer makes it the first and only claudin 18.2–targeted therapy approved in the U.S. for these indications, according to Astellas.
October 21, 2024
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2 min read
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Tristan Manalac
Pictured: Wall sign of the Novo Nordisk Foundation and Novo Holdings in Denmark
Mergers & acquisitions
Unions, Public Interest Groups Call on FTC to Challenge Novo Holdings-Catalent Acquisition
Pressure has been mounting for the Federal Trade Commission to take action, with Senator Elizabeth Warren last week urging FTC Chair Lina Khan to block the merger if it violates antitrust laws.
October 18, 2024
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2 min read
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Tristan Manalac
FDA sign outside its office in Maryland
Regulatory
FDA Pushes Back PDUFA Dates for Amgen and Intercept
The regulator has delayed its respective decision dates on whether to grant full approval to Amgen’s Lumakras in metastatic colorectal cancer and Intercept Pharmaceuticals’ Ocaliva for primary biliary cholangitis.
October 18, 2024
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2 min read
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Tristan Manalac
Pictured: Infant in the hospital wearing a ventila
RSV
Merck, Pfizer Tout Promising Respective Data in RSV With High Rates of Prevention
Merck’s investigational antibody clesrovimab demonstrated more than 60% effectiveness in reducing some types of respiratory syncytial virus-associated infections in infants, while Pfizer’s RSV vaccine Abrysvo showed 90% effectiveness at preventing the most severe RSV cases in adults 60 years and older.
October 18, 2024
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2 min read
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Tristan Manalac
Poznan, Poland – October 29, 2020: The Glaxosmithkline headquarters office building in Poznan. LOGO. GaxoSmithKline also called GSK is a British pharmaceutical company.
Infectious disease
GSK, ViiV Tout 99% Effectiveness for Long-Acting HIV PrEP as Gilead Gains Ground
Real-world evidence show that GSK and ViiV Healthcare’s long-acting pre-exposure prophylaxis Apretude can prevent nearly all HIV infections, while rival Gilead Sciences is moving quickly toward an approval for a twice-yearly option.
October 17, 2024
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2 min read
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Tristan Manalac
Bavarian Nordic's sign outside its facility in Germany
Vaccines
Bavarian Nordic’s Jynneos Elicits ‘Robust’ Mpox Antibody Response in Adolescents: Study
The mpox vaccine induced an antibody response in adolescents aged 12 to 17 years that matched that in adults, suggesting the shot can be used to protect the highly susceptible group.
October 17, 2024
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2 min read
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Tristan Manalac
Pictured: BMS sign on a building in San Diego, California/iStock, JHVEPhoto
Lymphoma
BMS’ Opdivo Bests Pfizer’s Adcetris in Late-Stage Hodgkin’s Lymphoma Study
Opdivo showed a 52% progression-free survival advantage over Adcetris in newly diagnosed Hodgkin’s lymphoma, according to a Phase III study that combined either therapy with doxorubicin, vinblastine and dacarbazine.
October 17, 2024
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2 min read
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Tristan Manalac
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